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CompletedNCT01948154Updated Jan 30, 2018

The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study

An observational study in Cerebral Palsy, Speech Function and Quality of Life, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 2 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Chang Gung Memorial Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
2 Years to 12 Years
Sex
All
01

Study summary

Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. It is not infrequently to note concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many studies have documented Cerebral palsy is associated with a variety of neuromotor disorders that frequently affect the speech production system. The speech function impairment varied widely due to different severity of diseases involved. The investigators hypothesize such impairment of speech function may affect degree of social participation and eventually the quality of life (QoL).

Read the detailed description

Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. It is not infrequently to note concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many studies have documented Cerebral palsy is associated with a variety of neuromotor disorders that frequently affect the speech production system. The speech function impairment varied widely due to different severity of diseases involved. The investigators hypothesize such impairment of speech function may affect degree of social participation and eventually the quality of life (QoL).

The investigators study aim in this project include: (1) to find the differences in speech function in normal developed children and in children with CP with different severity; (2) the relationship between speech function and QoL in children with CP; (3) to seek the predictable factor involving motor speech function in children with CP from the framework of International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY).

This will be a 3-year longitudinal project recruiting 110-130 children in total. The investigators will have children with CP (n=60\~80) and normal (n=50) from 2-12 years old under consent of their family. The investigator's study will be based on structure of ICF-CY. In the first year, basic clinical assessments including motor, mental, vocabulary, motor speech function, general development, and subjective questionnaires on adaptation, participation, development and quality of life will be collected. During the second to the third year, all measurements will be repeated in the end of 6- and 12-month to follow the performance of children with CP and those with normal development.

The anticipated outcomes of this study are: (1) to observe the longitudinal change of speech function and QoL in children with CP. (2) Using ICF-CY items in rehabilitation services to describe the speech function and participation of social life for children with CP. (3)To identify the influencing factors and predictors of motor speech function for children with CP.

02

Conditions studied

  • Cerebral Palsy
  • Speech Function
  • Quality of Life

Keywords

  • Cerebral Palsy
  • Early Intervention
  • Speech Function
  • Quality of Life
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 300 is above the median of 60 across 199 observational studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

We will have children with CP (n=60\~80) and normal (n=50) from 2-12 years old under consent of their family.

Eligibility criteria

  1. Subjects (Patients selection): A.50 healthy subjects B.30-40 2-5y11m y/o CP subjects C.30-40 6-12 CP subjects (children with cerebral palsy)

Inclusion Criteria:

Inclusion Criteria:

  1. Parents or guardians who signed informed consent
  2. Age 6-12 year old
  3. Diagnosed to have cerebral palsy

Exclusion Criteria:

  1. Concurrent medical condition (such as: seizure, infection)
  2. Surgery within 3 months
  3. Botulinum toxin-A injection within 3 months
  4. Concurrent progressive or degenerative diseases, peripheral neuropathy, spinal cord injury.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • children with CP

    Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. 2-12 years old (n=60-80)

  • normal child

    normal child 2-12 years old (50 subjects)

06

What researchers measure

Primary outcomes

  1. change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up

    change of CDIIT

    Time frame: baseline, 6 month, 12 month

Secondary outcomes

  1. change of Mental Ability

    change of Mental Ability (BSID-II, WPPSI-R, WISC-IV)in 6 month, 12 month follow up

    Time frame: baseline, 6 month, 12 month

Other outcomes

  1. change of Motor Speech in 6 month, 12 month

    Motor Speech Assessment (VMPAC, PCC)in 6 month, 12 month follow up

    Time frame: baseline, 6 month,12 month

  2. Language Assessment

    Language Assessment (PPVT-R; CLST)in 6 month, 12 month follow up

    Time frame: baseline, 6 month, 12 month

07

Study locations

1 site
  • Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01948154
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Sep 23, 2013
Start date
Feb 2013
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Jan 30, 2018

Study contacts

Katie P Wu, MD
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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